116. IND or Sponsor Protocol Amendments (§312.30)

Amendments for new protocol: Required when the sponsor intends to conduct a study that is not covered by a protocol already contained in the IND.

Amendment for changes to an existing protocol: Required for (1) any changes in a Phase 1 protocol that significantly affect the safety of subjects or (2) any changes in a Phase 2 or 3 protocol that significantly affect the safety of subjects, the scope of the investigation, or the scientific quality of the study.

Amendment for new investigator: Required when a new investigator is added to carry out a previously submitted protocol. A protocol amendment is not required when a licensed practitioner is added in the case of a treatment protocol.

Additionally, a sponsor may submit an information amendment to provide the FDA with essential information on the IND that is not within the scope of a protocol amendment, or IND safety or annual report.

Investigator Requirements for Informing the IRB of Sponsor Amendments

University and affiliate investigators must submit all sponsor amendments for IRB review. The submission should include a modification request listing and justifying the amendments, and copies of the relevant sponsor correspondence and the amended materials.

NOTE: If the sponsor requires specific language for IRB approval or authorization letters, investigators are advised to inform the IRB of those requirements.

IRB Review of Sponsor Amendments

Depending on the potential impact of the amendments, the IRB will review and either approve or acknowledge the amendment. Substantive amendments may require review at a convened IRB meeting. Alternatively, the IRB may use expedited procedures to review and acknowledge amendments that are administrative in nature, and neither alter the risk to benefit ratio of the study nor involve changes to study materials.